Oral formulations containing drugs are mostly tested in phosphate buffer saline (7.4 pH) and many research papers miss the dissolution or release behaviour of entrapped odrug in gastric fluid pH. Can any one give idea that what is technical reason behind it?? Why stomach pH studies are ignored in some research articles??
The conventional formulation mostly designed to release in stomach must be studied in gastric pH. Whenever sustained/controlled drug deliver systems are subjected for drug release study, first 2 hours study must be in gastric fluid, subsequent period must be in intestinal fluid.
Oral formulation should be at least studied at pH 1.2, 4.5 and 6.8 for drug release. But it is better to use biomimetic media such as FASSIF or FESSIF or for gastric conditions FASSGFor FESSGF. You should read the papers published by Jennifer Dressman, Germany and also the book she edited (Oral drug delivery). Using pH 7.4 buffer is not relevant for oral delivery testing.
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